Highlights:A Senior QA/QC leader -18 years in Pharmaceutical/biotech industries- with experience in overseeing and directing QA functions, initiatives and personnel for organizations in the pharmaceutical industry. Strong background in Quality Assurance (QA) and Quality Control (QC) functions. Ability to build and maintain a high-performing team, providing effective alignment and communication with functional groups at the site to successfully deliver on all commitments. Exemplary communication and interpersonal skills.

Skills:GXP, Good Manufacturing Practices (GMPs), FDA Inspection, GMP Audits, Deviations, CAPA, Change Control, Batch Disposition, 21 CFR part II, Quality Management System (QMS), Contract Service Provider (CSP) Management, Document Management System (DMS), MS Office Applications

Goal:To become a Quality Assurance leader within the next 2 years and assist Biopharmaceutical companies with the approval and commercialization of their candidate drug products

Certification:•Postgraduate Diploma, Pharmaceutical Quality Control Academy of Applied Pharmaceutical Sciences (AAPS), Toronto, Canada •Bachelor of Science (B.Sc.), Applied Chemistry Azad University of Tehran, Iran

Quality Assurance Director 01/2024 - current
Sigma Analytics Inc., Scarborough, Ontario Canada
Industry: Pharmaceutical
Quality oversight - Maintaining Quality management System (QMS) to ensure quality compliance regarding Health Canada and Cannabis Act
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Quality Assurance Director 01/2023 - 12/2023
Shields Pharma Inc., Markham, Ontario Canada
Industry: Pharmaceutical
Set up Quality Management System (QMS) for GMP testing laboratory facility as part of initial start up to ensure quality compliance regarding Health Canada Structured quality unit from ground zero Hosted Health Canada as part of initial DEL inspection and responded to regulatory inspection report.
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Director of Quality Assurance 05/2021 - 11/2022
Tricida Inc., San Francisco, California United States
Industry: Bio Pharmaceutical
Assisted in the quality oversight and management of GxP activities internally at Tricida and externally with vendors and service providers, including, but not limited to, inspection readiness and management, quality systems management, external document review and approval including batch disposition.
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Head of Quality 09/2017 - 12/2020
Avantie Rx Analytical Inc., Brampton, Ontario Canada
Industry: Pharmaceutical
Led both QA and QC team. Acted as Quality Assurance Person (QAP) with security clearance by HC. Maintained Quality management System (QMS) to ensure quality compliance regarding Health Canada, FDA, Eudralex, and Cannabis Act requirements.
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Associate Director, Quality Assurance 01/2013 - 08/2017
Nucro-Technics, Scarborough, Ontario Canada
Industry: Pharmaceutical
Auditing/inspecting/reviewing cGMP studies/projects conducted by Microbiology, Chemistry, Genetic Toxicology and Toxicology Laboratories. Hosted client audit and regulatory (Health Canada and FDA) inspections. Acted as a technical resource in drafting responses to the client and/or regulatory inspection reports.
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Laboratory Supervisor 11/2006 - 04/2012
Quality Compliance Laboratories, Markham, Ontario Canada
Industry: Pharmaceutical
Supervised QC team of 18 analysts. Involved with daily project assignment, trouble shooting, investigation and training laboratory staff.
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Azad Univercity of Tehran 09/1994 - 02/1998
Tehran, , Iran
Degree: Bachelor's Degree
Major:Applied Chemistry
Applied Chemistry

Tahameh Nikrou-Jun 2024